Table. Bleeding in two randomized controlled studies.
| WHO Bleeding Scale*1 |
Wandt et al. (12) | p-value | Stanworth et al. (13,22) | p-value | ||
|---|---|---|---|---|---|---|
| prophylactic | therapeutic | prophylactic | therapeutic | |||
| All patients Grade 2 and higher Grade 3 Grade 4 |
65/343 (19)*2 3 (1) 4 (1) |
127/301 (42) 7 (2) 13 (5) |
<0.001 ns 0.016 |
128/299 (43) 1(<1) 0 |
151/301 (50) 4 (1) 2 (1) |
0.04 ns ns |
| Autologous HSCT Grade 2 and higher Grade 3 Grade 4 |
8/98 (8) 0 0 |
29/103 (28) 1 (1) 0 |
0.0005 |
95/210 (45) 0 0 |
99/211 (47) 1 (0.5) 2 (1) |
ns |
| Acute leukemia Grade 2 and higher Grade 3 Grade 4 |
57/245 (24) 3 (1) 4 (2) |
98/198 (51) 6 (3) 13 (7) |
<0.0001 ns 0.0095 |
33/89 (37) 1 (1) 0 |
52/90 (58) 3 (3) 0 |
<0.05 ns |
*1WHO Grade 2: mild bleeding (more than isolated petechiae); no erythrocyte transfusion required; WHO Grade 3: bleeding requiring red cell transfusion; WHO Grade 4: symptomatic retinal or CNS bleeding; any life-threatening or fatal bleeding
*2absolute numbers (%)
WHO. World Health Organization; ns. non-significant; HSCT. hematopoietic stem cell transplantation